Assessing E-Cigarettes for Tobacco Harm Reduction in the Context of Lung Cancer Screening

This study investigates the feasibility, acceptability, and short-term effects of providing 4 weeks of complimentary electronic cigarettes (ECs) to 30 individuals who did not quit after smoking cessation treatment provided in the context of lung cancer screening and do not plan to quit smoking. This open-label single-arm pilot clinical trial will test the impact of EC provision on: 1) study feasibility, 2) EC acceptability, 3) tobacco use behavior (e.g., cigarettes per day, EC use), and 4) biomarkers (e.g., carbon monoxide, cotinine, and anabasine). Participants will be asked to switch from combustible cigarettes to the NJOY ACE 5% nicotine electronic cigarette (EC) for 4 weeks. They will be followed an additional 4 weeks after EC provision ends (to 8 weeks).

The first study hypothesis is that more than 40% of eligible smokers who are offered participation in the trial will enroll, and that 75% of enrollees will complete the trial. The second study hypothesis is that participants will report fewer cigarettes smoked per day at the end of 4 weeks of EC provision, relative to their baseline values.

Study Overview

• Status: Completed
• Conditions: Electronic Cigarette Use; Nicotine Dependence; Smoking, Cigarette
• Intervention / Treatment: Other: NJOY ACE e-cigarette

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants who completed the Screen Assist study (NCT03611881) and self-reported smoking cigarettes at the end of the study were asked to complete a survey to ascertain their potential interest in participating in a research study to test the effects of switching from combustible cigarettes (CC) to electronic cigarettes (EC). Individuals who expressed interest in switching to EC on that survey were screened for eligibility for this pilot study
• Smoked ≥5 cigarettes/day in past month
• Smoking status at study entry confirmed by breath carbon monoxide (CO) ≥ 6ppm
• Willing to try switching from CC to EC for 4 weeks
• Owns a mobile telephone
• English speaking
• Willing to travel to the Massachusetts General Hospital campus for 3 in-person visits.

Exclusion Criteria:

• Plans to quit smoking and has set a quit date in the next 30 days
• Used smoking cessation treatment in the past 30 days
• Used EC on >2 days in the past 30 days
• Hospitalized for acute coronary syndrome, unstable angina, congestive heart failure, stroke, pneumonia or chronic pulmonary disease/asthma exacerbation in the past 1 month
• Not willing to abstain from smoking marijuana in the 24h before each study visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NJOY ACE e-cigarette provision; Device: NJOY ACE e-cigarette, 5% nicotine in tobacco flavor Patients will be provided with a NJOY ACE electronic cigarette for 4 weeks and asked to use the NJOY ACE as a substitute for smoking combustible cigarettes during the 4 weeks.	Other: NJOY ACE e-cigarette; Patients will be provided with NJOY ACE electronic cigarettes and 5% nicotine e-liquid cartridges in tobacco flavor for 4 weeks and asked to use the electronic cigarette as a substitute for smoking combustible cigarettes during the 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Feasibility	Participant enrollment, measured by the proportion of eligible participants who enroll in the study. Retention is measured by weeks of study participation.	4 weeks
Cigarettes Per Day (CPD) Smoked During the Period of E-cigarette Provision	Change in self-reported CPD smoked in the past week assessed using timeline follow-back (TLFB) between baseline and end of e-cigarette provision (Baseline vs.Week 4)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carbon Monoxide (CO) Concentration in Expired Air	Change in participant's expired air carbon monoxide (CO) concentration assessed via Smokerlyzer during the period of e-cigarette provision (Baseline vs.week 4)	4 weeks
Cigarettes Smoked Per Day After E-cigarette Provision Ends	Self-reported number of cigarettes smoked per day in the past week between end of e-cigarette provision and end of study (week 4 to week 8)	4 weeks (Weeks 4-8)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Dana-Farber Cancer Institute; University of Massachusetts, Boston
• Investigators: Principal Investigator: Nancy A. Rigotti, MD, Massachusetts General Hospital; Principal Investigator: Jaqueline C Avila, PhD, University of Massachusetts, Boston

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2024
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): December 30, 2025

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: June 19, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Tobacco Use Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Smoking; Tobacco Smoking; Tobacco Use; Tobacco Use Disorder; Vaping; Cigarette Smoking
• Other Study ID Numbers: 2024p001502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No